A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life Inventory
研究概览
简要总结
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.
详细描述
Primary Objective:
To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.
Secondary Objectives:
To assess the impact of AR versus non-AR control technology in pediatric oncology patients, including:
- Inpatient opioid use
- Average daily inpatient pain score
- Number of opioid requests during hospital stay
- Inpatient PedsQL (quality of life) questionnaire score
- Ambulation/"out of bed" movement
- Number days to discharge-ready status
- Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team
- Outpatient opioid use reported at 30, 60, 90 days.
- Outpatient pain scores reported at 30, 60, 90 days
- Outpatient PedsQL scores reported at 30, 60, and 90 days
- Potential adverse events related to the use of AR (i.e., falls).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English and Spanish-speaking parents/legal guardians and patients
- •Undergoing surgery requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- •Expected to be prescribed postoperative inpatient opioids
- •Prescribed daily opioids for pain for a period equal to or longer than 30 days before surgery.
- •Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
- •Both the child and a legal guardian are willing and able to provide informed consent.
- •The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (>15 years of age) were disinterested in the interactive game.
排除标准
- •Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
- •Inability to demonstrate an understanding of the game from English instructions
- •Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
结局指标
主要结局
Pediatric Quality of Life Inventory
时间窗: through completion of study, an average of 1 year
Quality of life assessment: Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.
次要结局
未报告次要终点